An observational study in Arrhythmogenic Cardiomyopathy, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-10-13.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
This study aims to identify novel inflammatory biomarkers in AC, whether in circulating blood, in situ or as imaging biomarkers to better understand the pathophysiology of the disease and then to determine contribution to the clinical management of patients.
The treatment of AC remains based on palliative measures aimed at treating the consequences of the disease: antiarrhythmic treatments, defibrillator, treatments for heart failure. The identification of new biomarkers, in particular circulating ones, would make it possible to open pathophysiology avenues which, in the long term, could lead to therapies targeted to autoimmunity or inflammation.
Many scientific and medical questions remain unanswered and require precise databases on the diagnostic and prognostic evaluation of this pathology.
The objective of this study is to identify novel inflammatory biomarkers in patients with AC by studying the autoimmunity, inflammatory, and immunological profiles through blood samples and myocardial biopsies.
1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.
This study's planned enrollment of 300 is above the median of 153 across 515 observational studies indexed under Cardiomyopathies.
Browse Cardiomyopathies studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All adult patients with clinical or preclinical Arrhythmogenic Cardiomyopathy (carrier of risk mutation). The retrospective patients will be informed by mail and the prospective patients will be informed during their routine care visit, both using the opt-out approach.
Exclusion Criteria:
Biological: Prospective
Other: Retrospective
-Additional blood samples -Myocarditis biopsy sample (routine care) -Additional pericardial fluid sample (routine care)
None (only data collection)
Measure the correlation between the autoimmunity, inflammatory, and immunological profiles through biomarkers found in blood samples, myocardial biopsies, mass imaging cytometry, and cardiac imaging in patients with Arrhythmogenic Cardiomyopathy (AC)
Time frame: 10 years
Measure the correlation between circulating biomarkers and the severity of the phenotype determined by the severity of AC and multi-modality imaging
Time frame: 10 years
Measure the correlation between imaging biomarkers and electrocardiogram (ECG) parameters (presence of repolarization and depolarization abnormalities)
Time frame: 10 years
Measure the changes in inflammatory biomarkers in serum and cardiac imaging over time
Time frame: 10 years
Demonstrate a correlation between circulating and imaging biomarkers and the link between the extent of fibro-adipose infiltrates and the ventricular strain
Time frame: 10 years
Measure the correlation between circulating and imaging biomarker values and electro-anatomical mapping data
Time frame: 10 years
Screening for cardiotropic virus in pericardial fluid and circulating blood sampled in routine care during epicardial ablation by PCR
Time frame: 10 years
Measure the correlation between the presence of a pathogenic or common genetic variant and serum/imaging biomarkers.
Time frame: 10 years
Plan to share: Yes — Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission Nationale de l'Informatique et des Libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris